Home › Biobase Biodustry(Shandong)Co., Ltd. › BIOBASE
BIOBASE
Biobase Biodustry(Shandong)Co., Ltd. · Model BK-9621 · UDI-DI 06936895300083
10
510(k) clearances
7,712
Adverse events
9
Recalls
21
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-03-22 | Becton Dickinson & Co. | Upon installation of BD Kiestra" InoqulA+" and BeA version 5.1 and 5.1.1 as part of the Icefall A platform, plate information was not visible in Synapsys" after processing has occu |
| 2019-07-26 | Becton Dickinson & Co. | An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate |
| 2019-07-26 | Becton Dickinson & Co. | An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate |
| 2013-08-09 | Copan Italia | The recall of the WASP (Walk Away Specimen Process) instrument was initiated because Copan Italia SpA has upgraded the software concerning the broth inoculation table feature. The |
| 2009-04-09 | Hamilton Co | Product Defect-- some tips from the mold cavity 28 are too short and do not always aspirate or dispense liquid correctly. |
| 2008-12-01 | Hamilton Co | Some tips may be occluded and are unable to aspirate or dispense liquid. |
| 2007-06-25 | Hamilton Co | Incorrectly labeled-- Product has the wrong barcode labeling. The barcode error will not influence the results of testing. The instrument will discover the error and post an error |
| 2005-12-13 | Hamilton Co | Heat sinking on power boards may not operate as intended and the board may cease to operate. |
| 2004-05-20 | Diasorin Inc. | When software was updated for the Washer program of the Bio Tek Automated Microplate Washer Model ELx50, the software did not automatically clear old versions of the wash program w |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.